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Tebipenem pivoxil granule and preparation method thereof

A technology of tipipenem ester and tipipenem, which is applied in the direction of medical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve problems such as discomfort and improve compliance , improve stability, and easily expand production

Inactive Publication Date: 2014-12-24
BEIJING JIMEITANG MEDICINE RES CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this carbapenem antibiotic itself has a bitter taste or a special taste, which will cause discomfort when taken, so it needs to be solved by taste masking technology and / or adding flavoring agents

Method used

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  • Tebipenem pivoxil granule and preparation method thereof
  • Tebipenem pivoxil granule and preparation method thereof
  • Tebipenem pivoxil granule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0019]

[0020]

[0021] Composition of resin coating layer:

[0022]

[0023] Composition of the powder coating layer:

[0024]

[0025] Preparation Process:

[0026] (1) Ball core preparation:

[0027] a. Take tipipenem ester, microcrystalline cellulose, lactose, and carboxymethyl starch sodium and pass through a 60-mesh sieve respectively, and set aside;

[0028] b. Take the tipipenem ester, microcrystalline cellulose, lactose, and sodium carboxymethyl starch in the prescribed amount, mix them evenly, and set aside;

[0029] c. Mix powder and add water to make soft materials, and put them in an extrusion spheronizer to granulate;

[0030] d. Fluidized bed drying, drying temperature 50 ℃;

[0031] (2) Resin layer coating:

[0032] a. Take purified water, stir and add the coating material of Youteqi series, talcum powder, sodium lauryl sulfate and stir evenly;

[0033] b. Turn on the fluidized bed, add granules to preheat, and carry out coating. The coating ...

Embodiment 2

[0038]

[0039] Composition of resin coating layer:

[0040]

[0041] Composition of the powder coating layer:

[0042]

[0043] Preparation Process:

[0044] (1) Ball core preparation:

[0045] a. Take tipipenem ester, microcrystalline cellulose, lactose, and sodium carboxymethyl starch and pass through an 80-mesh sieve respectively, and set aside;

[0046] b. Take the tipipenem ester, microcrystalline cellulose, lactose, and sodium carboxymethyl starch in the prescribed amount, mix them evenly, and set aside;

[0047] c. Mix the powder and add water to make a soft material, and put it in an extrusion spheronizer to granulate;

[0048] d. Fluidized bed drying, drying temperature 60 ℃;

[0049] (2) Resin layer coating:

[0050] a. Take purified water, stir and add the coating material of Youteqi series, talcum powder, sodium lauryl sulfate and stir evenly;

[0051] b. Turn on the fluidized bed, add granules to preheat, and carry out coating. The coating temperat...

Embodiment 3

[0056]

[0057] Composition of resin coating layer:

[0058]

[0059] Composition of the powder coating layer:

[0060]

[0061] Preparation Process:

[0062] (1) Ball core preparation:

[0063] a. Take tipipenem ester, microcrystalline cellulose, lactose, and carboxymethyl starch sodium and pass through a 100-mesh sieve respectively, and set aside;

[0064] b. Take the tipipenem ester, microcrystalline cellulose, lactose, and sodium carboxymethyl starch in the prescribed amount, mix them evenly, and set aside;

[0065] c. Mix the powder and add water to make a soft material, and put it in an extrusion spheronizer to granulate;

[0066] d. Fluidized bed drying, drying temperature 50 ℃;

[0067] (2) Resin layer coating:

[0068] a. Take purified water, stir and add the coating material of Youteqi series, talcum powder, sodium lauryl sulfate and stir evenly;

[0069] b. Turn on the fluidized bed, add granules to preheat, and carry out coating. The coating temperat...

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Abstract

The invention relates to a tebipenem pivoxil granule and a preparation method thereof. The granule is prepared according to the following steps: uniformly mixing tebipenem pivoxil, microcrystalline cellulose, lactose and carboxymethyl starch sodium, adding water to prepare a soft material, putting in a ball rolling machine for extruding and preparing pills, and drying by using a fluidized bed, and dressing. The dressing layer comprises a resin layer and a powder coating. The preparation method is capable of guaranteeing medicine stability through a special dressing prescription under the prerequisite of keeping the dissolution effect, and also is capable of masking the bitterness of the granule and improving the mouthfeel. The preparation method is simple in operation, short in man hour, high in yield and suitable for industrialized production.

Description

technical field [0001] The invention relates to a pharmaceutical preparation and a preparation method thereof, in particular to a pharmaceutically acceptable tipipenem axetil granule for children with pneumonia, ENT and upper respiratory tract infections, and belongs to the technical field of western medicine preparations. Background technique [0002] Tipipenem ester fine granules, first developed by Japan Meiji Seika Co., Ltd., was launched in Japan in April 2009. It is a new broad-spectrum antibiotic of oral carbapenems, used for children's pneumonia, ENT and upper respiratory tract Infection treatment. Tipipenem axetil is a carbapenem antibiotic and is unstable to water. Therefore, oral preparations can be dry granulated or compressed into tablets. Considering that children cannot use tablets for a long time and patients with difficulty swallowing, granules are preferred. . However, this carbapenem antibiotic itself has a bitter or special taste, which will cause disco...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/427A61K47/32A61K47/38A61P31/04
Inventor 李燕王旭东齐亚青
Owner BEIJING JIMEITANG MEDICINE RES CO LTD
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